Efficacy of sacral nerve root magnetic stimulation in primary premature ejaculation: mechanistic and clinical...

Primary premature ejaculation (PPE) is a common lifelong sexual disorder that adversely affects sexual satisfaction and quality of life (QoL), and current treatments have limitations in efficacy, tolerability, or durability.

To evaluate the clinical efficacy, safety, and feasibility of sacral nerve root magnetic stimulation (SNRMS) vs sham in men with PPE.

From July 2023 to September 2024, we conducted a prospective, single-blind, randomized, sham-controlled trial. Fifty-three men meeting ISSM criteria for PPE (age 18-65, stable sexual relationship) were randomized 1:1. Active stimulation used a Magneuro60F coil positioned over S2-S4. Sham delivered identical coil placement and initial low-intensity pulse but no therapeutic output thereafter. Randomization used computer-generated permuted blocks with allocation concealment by sealed envelopes; patients were blinded, and outcome assessors/statisticians remained masked. Analyses used intention-to-treat principles; continuous outcomes reported as mean ± SD with 95% CI and Cohen's d; categorical outcomes compared with Fisher's exact test.

Primary outcome was change in intravaginal ejaculatory latency time (IELT) measured by stopwatch at 6 months after treatment completion; treatment success defined as IELT ≥90 s at 6 months. Secondary outcomes included Premature Ejaculation Profile (PEP), sexual satisfaction (5-point Likert), International Index of Erectile Function (IIEF-5), Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), SF-12 QoL, and adverse events.

At 6 months, mean IELT increased from 37.4 ± 13.7 to 92.1 ± 46.4 s in the SNRMS group (mean change 54.7 s; 95% CI, 38.2-71.1; Cohen's d = 1.37). Treatment success (IELT ≥90 s) occurred in 33.3% (9/27) of SNRMS participants. PEP, sexual satisfaction, SAS, SDS, and SF-12 mental scores improved significantly more with SNRMS (all P < .01). Adverse events were mild and transient; no serious adverse events occurred.

Sacral nerve root magnetic stimulation is a promising non-invasive therapy that can substantially prolong IELT and improve sexual and psychological outcomes in men with PPE, potentially offering a durable alternative to daily pharmacotherapy.

Strengths include prospective randomized sham-control, blinded outcome assessment, and multi-domain outcomes with 6-month follow-up. Limitations include single-center design, modest sample size limiting subgroup analyses, lack of objective neurophysiological measures (electromyography [EMG]/functional MRI [fMRI]) to confirm mechanisms, and the need to confirm durability beyond 6 months.

In this randomized sham-controlled study, SNRMS produced clinically and statistically significant improvements in IELT, ejaculatory control, sexual satisfaction, and psychological well-being in men with PPE.